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And on Monday, Colorado Democratic Governor Jared Polis urged elderly residents of his state to seek third doses of the vaccine. “If you’re 70, 80, if you have a weakened immune system, go ahead and get that booster today,” he said at a press conference, noting that those who want the dose additional do not need a medical certificate.
The combination of aggressive state action and the backlash from health experts against Biden’s plan has amplified confusion over who needs boosters now, as the highly contagious Delta variant rips through. the country. Some doctors are already recommending or giving boosters to patients outside of the small group of severely immunocompromised people who are already eligible for the injections.
“There has been just a yoyo of messages,” West Virginia Covid response manager Clay Marsh told POLITICO.
“Even for people like us who follow, we’re confused,” he added, pointing to two career FDA scientists who signed a trial last week in The Lancet reviewing the case to offer boosters. to the general population.
The FDA’s independent vaccine advisory committee on Friday voted against approving the Pfizer-BioNTech recall for Americans 16 years of age and older, citing concerns about the quality of the data, its safety and efficacy. The panel instead approved the vaccine’s authorization for people 65 years of age and older and those at high risk of serious illness, and then agreed, through an unofficial straw poll, that the vaccine should be offered. healthcare workers and others exposed to Covid at work.
Attention is now on the FDA, which was set to approve the Pfizer-BioNTech booster as early as this weekend. The agency is under no obligation to follow the recommendations of its advisory group, but it could face serious public backlash if it accepts the widespread use of boosters in defiance of the group’s actions.
The agency was already grappling with skepticism about the extent to which seemingly diminishing protection against infection warrants stepping up as most populations remain safe from serious illness, hospitalizations and death. The FDA is also due to make decisions on boosters from Moderna and Johnson & Johnson in the coming weeks.
The final step in the regulatory process for the Pfizer-BioNTech recall will take place on Wednesday and Thursday, when the CDC’s vaccine advisory committee meets to determine if and how doses should be administered. While the FDA must give the regulatory green light for boosters, the CDC panel is determining how the injections are administered – which populations should be injected first and how long after their second dose.
Agency scientists indicated last month that they were inclined to recommend that residents of long-term care homes and frontline healthcare workers be given priority for recalls.
Senior officials in the Biden administration have relied heavily on data from Israel’s vaccination campaign, including its booster deployment, to guide their decision-making. An analysis published in the New England Journal of Medicine on Wednesday found that the boosters increased protection in people 60 and older for a few weeks, but the study did not look at effectiveness over a longer period. FDA scientists said last week that Israel’s data in itself was not convincing evidence that boosters should be given.
But that hasn’t swayed heads of state hungry for another weapon in the fight against the virus.
“We are ready to recall as soon as we get the green light,” West Virginia Gov. Jim Justice, a Republican, said on Wednesday. The state is experiencing its worst surge to date, with no signs of new infections having started to level off or decline.
“I strongly, strongly encourage [FDA] to approve these and approve people to go who are six months away from their last dose, Justice said. “We have many, many great West Virgins who are well beyond six months… and now we have people who are desperately, desperately in need of this reminder.”
The White House told governors on a call last week that it plans to provide states with recall advice by the end of next week, Arkansas Gov. Asa Hutchinson said on Tuesday. Meanwhile, the CDC emailed states last week asking them not to offer boosters until “after the FDA takes regulatory action and ACIP and CDC have makes clinical recommendations for use ”.
But Hogan of Maryland is not waiting for federal action. It took the step of allowing booster doses for the elderly at assembly locations based on data from antibody tests in August from more than 500 nursing home residents across the state. Over 60% “demonstrated some form of declining immunity over time” and up to a third were now “particularly vulnerable,” he said.
Hogan’s announcement betrayed the confusion around boosters since Team BIden’s announcement last month. The governor of Maryland incorrectly said CDC advisers approved priority boosters for nursing home residents.
Yet Hogan’s decrees pointedly eschew the term “recall,” instead ordering eligible facilities to “offer the option” of an “additional dose” of Covid vaccine to residents. Federal health authority approval in August of third doses for moderately to severely immunocompromised Americans who initially received the Pfizer or Moderna vaccine allows them to self-certify their eligibility, although the CDC lists some conditions for which he recommends that patients receive another injection. . None of them are based on age alone.
“The CDC takes a broad view of what is considered immunosuppressed,” said Hogan communications director Michael Ricci. “We are building on this broader vision to view older people in community settings as immunocompromised.”
West Virginia has applied to the White House for permission to make the state a pilot site for the early administration of recalls, Marsh told POLITICO, given the state’s unprecedented hospitalization rate and intensive care unit beds occupied by Covid patients. Federal officials were sympathetic, he said, but would not take the plunge in the regulatory process.
“It just boiled down to, ‘the FDA has to make this decision,’ Marsh said.
Hogan, Justice and Polis touted data from Israel showing that a booster dose of Pfizer vaccine reduces the rate of severe illness in the elderly by a factor of 20. Getting third doses in the arms of their residents, say -they, will be critical to maintaining adequate protection against the virus as the highly contagious Delta variant tears apart the unvaccinated population that politicians are still trying to inoculate.
“This is really the next phase of adding an extra level of protection against the virus, both at the individual level – to give that person a higher degree of protection – but also at the population level,” Polis said Monday at a press conference.
“It also helps reduce the spread,” he added, noting that the main way to reduce infection rates is for people to get their initial round of vaccines.
Many public health experts have disputed Israel’s data, including results recently published in the New England Journal of Medicine. The authors followed booster recipients aged 60 or older for up to 12 days after injection. They did not attempt to determine whether the decrease in immunity after the initial vaccination was a product of time, as Pfizer claims, or of the emergence of Delta.
But for state governors and health officials, the situation on the ground is pushing Washington to act quickly.
West Virginia set records last week with 922 patients hospitalized with Covid on Friday, including 277 in intensive care. “We saw a substantial increase in our all-time records, and we got there 100 days faster than in our last wave in December,” said Marsh.
West Virginia is generally older and has more underlying health issues, such as diabetes and heart problems, than other Americans, Justice said Wednesday, making them more susceptible to the worst effects of Covid.
“Our general public, we have been the target of this disease from the start,” Justice said, “and to protect ourselves in any way we can, I absolutely believe that if there is a state that needs to boost it for the general public, it’s probably us.
Erin Banco and Dan Goldberg contributed to this report.
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